Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station
FDA device recall Z-1182-2007 · posted 2007-09-05 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Incorrect Patient Assignment: the information center will in most cases be associated with the "incorrect" patient. This occurs on both standalone and networked systems running fixed mode monitoring. (This does not occur on systems that run flex mode monitoring)
- Action taken
- Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 76 units
- Distribution
- Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK
- Date initiated
- 2007-07-16
- Date posted
- 2007-09-05
- Date terminated
- 2016-08-01
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) (K062271) | Philips Medical Systems | 2006-11-30 |